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This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| licarbazepine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| licarbazepine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of treatment with licarbazepine over 52 weeks. | ||
| with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | La Palma | California | 20623 | United States | ||
| Novartis Investigational Site |
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| Kansas City |
| Kansas |
| United States |
| Novartis Investigational Site | Shreveport | Louisiana | United States |
| Novartis Investigational Site | Somerville | Massachusetts | United States |
| Novartis Investigational Site | Farmington Hills | Michigan | United States |
| Novartis Investigational Site | Staten Island | New York | United States |
| Novartis Investigational Site | Madison | Tennessee | United States |
| Novartis Investigational Site | Bellaire | Texas | United States |
| Novartis Investigational Site | Dallas | Texas | United States |
| Novartis Investigational Site | Verdun | Texas | United States |
| Novartis Investigational Site | Bellevue | Washington | United States |
| Novartis Investigational Site | Kirkland | Washington | United States |
| Novartis Investigational site | West Allis | Wisconsin | United States |
| Novartis Investigational Site | Vienna | Austria |
| Novartis Investigational Site | Greater Sudbury | Canada |
| Novartis Investigational Site | Kelowna | Canada |
| Novartis Investigational Site | London | Canada |
| Novartis Investigational Site | Montreal | Canada |
| Novartis Investigator Site | Vancouver | Canada |
| Novartis Investigational Site | Bogotá | Colombia |
| Novartis Investigational Site | Medellín | Colombia |
| Novartis Investigational Site | Pareira | Colombia |
| Novartis Investigational Site | Brno | Czechia |
| Novartis Investigational Site | Hradec Králové | Czechia |
| Novartis Investigational Site | Prague | Czechia |
| Novartis Investigational Site | Berlin | Germany |
| Novartis Investigational Site | Bochum | Germany |
| Novartis Investigational Site | Dresden | Germany |
| Novartis Investigational Site | Ingolstadt | Germany |
| Novartis Investigational Site | Mannheim | Germany |
| Novartis Investigational Site | Würzburg | Germany |
| Novartis Investigational Site | Guatemala City | Guatemala |
| Novartis Investigational Site | Lima | Peru |
| Novartis Investigational Site | Moscow | Russia |
| Novartis Investigational Site | Yaroslavl | Russia |
| Novartis Investigational Site | Bojnice | Slovakia |
| Novartis Investigational Site | Michalovce | Slovakia |
| Novartis Investigational Site | Durban | South Africa |
| Novartis Investigational Site | Dnipro | Ukraine |
| Novartis Investigational Site | Kiev | Ukraine |
| Novartis Investigational Site | Luhansk | Ukraine |
| Novartis Investigational Site | Odesa | Ukraine |
| Novartis Investigational Site | Simferopol | Ukraine |
| Novartis Investigational Site | Caracas | Venezuela |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C428744 | 10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide |
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